The Clinical Assessment of Nigella Sativa Oil vs Chlorohexidine as a Therapeutic Aid for Gingivitis, Effect on Gingival IL-6 and IL-18 and Antimicrobial Efficacy.

NCT05069246 | Completed Phase 2

• 1 other identifier: PNU-IRB: 20-0261
• Study Type: interventional
• Target: 37
• Locations: 1 country
• Sites: 1

Brief Summary

A double-blind randomized clinical trial was conducted for 14 days with 37 systemically healthy patients having chronic generalized gingivitis. The current study was designed to investigate the anti-inflammatory and antimicrobial efficacy of Nigella Sativa oil compared with chlorohexidine; assessing clinical parameters and gingival interleukin 6 (IL6) and interleukin 18 (IL18) levels and supra-gingival plaque analysis.

Conditions

Gingivitis

Outcome Measures

Primary Outcomes (4)

• Gingival index

  Day 0 and day 15

• Plaque index

  Day 0 and day 15

• IL-6 levels

  Measurement of IL-6 in GCF samples

  Day 0 and day 15

• IL-18 levels

  Measurement of IL-18 in GCF samples

  Day 0 and day 15

Secondary Outcomes (2)

• Bacterial load

  Day 0 and day 15

• Inhibition of types of bacterial growth

  Day 0 and day 15

Other Outcomes (1)

• Feedback on any adverse effects and likes/dislikes of the intervention from participants

  Day 15

Study Arms (2)

Group 1 / Nigella Sativa oil / NS

EXPERIMENTAL

Group 1- Nigella Sativa (NS) N. sativa oil (Al-Hussan Food Products Factory, Riyadh, Kingdom of Saudi Arabia), which was brought from the local market in Riyadh. Each participant was given a 3 weeks supply of oil, and a sterile plastic 15ml graduated measuring cap. They were asked to measure 5ml of oil into the cap and add 5ml of normal drinking water to this and rinse their mouth for 3mins with this solution and spit it out at the end. This was done morning and evening for 14 days. Group 1: Maintained adequate plaque control levels using mechanical methods + N.sativa oil (5ml oil + 5ml water) pulling for 3 mins twice daily in the morning and at night (after brushing/breakfast in the morning, and after brushing and before sleeping at night). Unified oral hygiene instructions and instructions for each intervention were provided to all participants.

Other: Nigella Sativa oil

Group 2 / Chlorohexidine / CHX

ACTIVE COMPARATOR

Group 2- Chlorohexidine (CHX). Chlorohexidine (Middle East Pharmaceutical Industries Ltd, Riyadh, Kingdom of Saudi Arabia). Each participant was given a 3 week supply of chlorohexidine. They were asked to use 10ml of CHX morning and evening, rinsing their mouth for 3 mins and then spit it out at the end. This was done morning and evening for 14 days. Group2: maintained adequate plaque control levels using mechanical methods + chlorohexidine rinse twice daily 10ml in the morning and at the night (after brushing/breakfast in the morning, and after brushing and before sleeping at night). Unified oral hygiene instructions and instructions for each intervention were provided to all participants.

Drug: Chlorhexidine mouthwash

Interventions

Nigella Sativa oil OTHER

5ml Nigella Sativa oil mixed into 5ml water prior to use and rinsed in the mouth for 3 mins and spitted out, used twice a day; morning and evening.

Group 1 / Nigella Sativa oil / NS

Chlorhexidine mouthwash DRUG

10ml of chlorohexidine mouthwash used for 3mins and spit out, used twice a day; morning and evening.

Group 2 / Chlorohexidine / CHX

Eligibility Criteria

• Age: 20 Years - 40 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• At least 20 natural teeth
• Patients with moderate to severe gingivitis
• No tooth attachment loss

You may not qualify if:

• Periodontitis
• Cigarette smokers
• Antibiotic therapy (within the last 3 months)
• Systemic diseases
• Pregnant women
• Lactating women
• Current orthodontic treatment
• Using an intra-oral artificial prosthesis
• Using other chemical agents as a mouthwash

Sponsors & Collaborators

• Ishrat Rahman: lead

Study Sites (1)

Princess Nourah bint Abdulrahman University Dental Clinic

Riyadh, Saudi Arabia

Location

MeSH Terms

Conditions

Gingivitis

Interventions

Nigella sativa oil

Condition Hierarchy (Ancestors)

Infections; Gingival Diseases; Periodontal Diseases; Mouth Diseases; Stomatognathic Diseases

Study Officials

• Ishrat Rahman

  Princess Nourah Bint Abdulrahman University

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: September 18, 2021
• First Posted: October 6, 2021
• Study Start: December 8, 2020
• Primary Completion: December 24, 2020
• Study Completion: February 28, 2021
• Last Updated: October 6, 2021

Record last verified: 2021-09

Locations

SA (1)